BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 17367417 · Received July 20, 2023

    Report

    Report Number
    3002682307-2023-00200
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 28, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 230203. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE A VIAL PARTICLE WAS OBSERVED WITHIN THE SYRINGE PRODUCT. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD¿ BLUNT FILL NEEDLE PERFORATED RUBBER FROM AN AMPULE AND IT STUCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WOULD LIKE TO HAVE THIS PHOTO REVIEWED, THERE HAVE BEEN 2 INCIDENTS THAT A PIECE HAS STUCK. REASON: WE HAVE FOUND IN OUR HOSPITAL IN 1 DEPARTMENT 2X IN QUICK SUCCESSION A PIECE OF RUBBER AFTER A LIQUID HAS BEEN PULLED UP FROM AN AMPULE, THROUGH A RUBBER SEAL ON THE AMPULE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD¿ BLUNT FILL NEEDLE PERFORATED RUBBER FROM AN AMPULE AND IT STUCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WOULD LIKE TO HAVE THIS PHOTO REVIEWED, THERE HAVE BEEN 2 INCIDENTS THAT A PIECE HAS STUCK. REASON: WE HAVE FOUND IN OUR HOSPITAL IN 1 DEPARTMENT 2X IN QUICK SUCCESSION A PIECE OF RUBBER AFTER A LIQUID HAS BEEN PULLED UP FROM AN AMPULE, THROUGH A RUBBER SEAL ON THE AMPULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715924 BD¿ BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230203

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown